Diabetes Mellitus Type 2Phase 2NCT02397447
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
A Phase 2 study testing Momordica charantia in people with Diabetes Mellitus Type 2, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Momordica charantia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study
- Fasting glucose: <210 mg/dl
- A1C: 7-9%
- Body mass index: 25-34.9 kg/m2
- Body weight without variations above or under 5% in the last three months before entering the study
- Women in childbearing years must have a contraceptive method
- Letter of consent and release signed by each patient
Who cannot join
- Pregnant or suspected pregnant women
- Woman breastfeeding
- Medications known to affect metabolism of glucose and insulin
- Personal history of liver or renal disease
- Hypertension, thyroid or cardiovascular disease decompensated
- Total cholesterol >= 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate <=60ml/min or liver transaminases >=2.5 the upper normal limit
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
Read the detailed description
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.
An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.
Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Momordica charantia, Placebo
- Keywords
- Momordica Charantia, Insulin secretion, Insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momordica charantiaDrug
Also called Bitter gourd, karela, balsam-pear
Momordica Charantia: 2000 mg per day for three months
PlaceboDrug
Also called Calcined magnesia
Placebo: 2000 mg per day for three months
| Study group | Role | What they receive |
|---|---|---|
| Momordica charantia | Experimental | Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Receives: Drug: Momordica charantia |
| Placebo | Placebo comparator | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively
Measured: 90 days
Insulin Sensitivity (Matsuda Index) After 90 Days
Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]
Measured: 90 days
Secondary outcomes (19)
Fasting Serum Glucose (FSG) After 90 Days
The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1
Measured: 90 days
A1C After 90 Days
A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively
Measured: 90 days
Total Cholesterol After 90 Days
The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Triglycerides After 90 Days
The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Very Low Density Lipoprotein After 90 Days
The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5
Measured: 90 days
Alanine Aminotransferase (ALT) After 90 Days
The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Aspartate Aminotransferase (AST) After 90 Days
The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Creatinine After 90 Days
The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method
Measured: 90 days
Systolic Blood Pressure After 90 Days
The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg
Measured: 90 days
Diastolic Blood Pressure After 90 Days
The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg
Measured: 90 days
Body Weight (BW) After 90 Days
The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.
Measured: 90 days
Body Mass Index (BMI) After 90 Days
The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres
Measured: 90 days
Fat Mass After 90 Days
Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Measured: 90 days
Waist Circumference (WC) After 90 Days
The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters
Measured: 90 days
2-h Serum Glucose After 90 Days
The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1%
Measured: 90 days
AUC-glucose After 90 Days
The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days
Measured: 90 days
AUC-insulin After 90 Days
The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Martínez-Abundis, University of Guadalajara
- Investigators
- Esperanza Martínez Abundis, PhD Science, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397447
- Sponsor's protocol ID
- MCHDM2
- Status last verified
- Sep 2020
- First submitted
- 10 Mar 2015
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT02397447
- Acronym / sponsor ID
- MCHDM2
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Momordica Charantia, Insulin secretion, Insulin sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
Detailed description
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.
An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.
Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momordica charantia | Experimental | Drug: Momordica charantiaTwo 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study
- Fasting glucose: <210 mg/dl
- A1C: 7-9%
- Body mass index: 25-34.9 kg/m2
- Body weight without variations above or under 5% in the last three months before entering the study
Key exclusion criteria (6 listed)
- Pregnant or suspected pregnant women
- Woman breastfeeding
- Medications known to affect metabolism of glucose and insulin
- Personal history of liver or renal disease
- Hypertension, thyroid or cardiovascular disease decompensated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Momordica charantiaAlso: Bitter gourd, karela, balsam-pearMomordica Charantia: 2000 mg per day for three months | Drug | Momordica charantia |
| PlaceboAlso: Calcined magnesiaPlacebo: 2000 mg per day for three months | Drug | Placebo |
Primary outcome
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
Time frame: 90 days
Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively
Insulin Sensitivity (Matsuda Index) After 90 Days
Time frame: 90 days
Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]
19 secondary outcomes
Fasting Serum Glucose (FSG) After 90 Days
Time frame: 90 days
A1C After 90 Days
Time frame: 90 days
Total Cholesterol After 90 Days
Time frame: 90 days
Triglycerides After 90 Days
Time frame: 90 days
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
Time frame: 90 days
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
Time frame: 90 days
Very Low Density Lipoprotein After 90 Days
Time frame: 90 days
Alanine Aminotransferase (ALT) After 90 Days
Time frame: 90 days
Aspartate Aminotransferase (AST) After 90 Days
Time frame: 90 days
Creatinine After 90 Days
Time frame: 90 days
Systolic Blood Pressure After 90 Days
Time frame: 90 days
Diastolic Blood Pressure After 90 Days
Time frame: 90 days
Body Weight (BW) After 90 Days
Time frame: 90 days
Body Mass Index (BMI) After 90 Days
Time frame: 90 days
Fat Mass After 90 Days
Time frame: 90 days
Waist Circumference (WC) After 90 Days
Time frame: 90 days
2-h Serum Glucose After 90 Days
Time frame: 90 days
AUC-glucose After 90 Days
Time frame: 90 days
AUC-insulin After 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esperanza Martínez Abundis, PhD Science principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Momordica charantia in people with Diabetes Mellitus Type 2, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.